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Effect of transcranial magnetic stimulation on response inhibition and craving in people with alcohol use disorder

The effect of single session intermittent theta burst stimulation (iTBS),over right inferior frontal gyrus (IFG) on response inhibition, cortical plasticity and craving in alcohol use disorder patients (AUD), a proof of concept study - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/09/057196
Enrollment
40
Registered
2023-09-01
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F102- Alcohol dependence

Interventions

Intervention1: single session of intermittent theta burst stimulation over right inferior frontal gyrus: The stop signal task will be administered using a computer based software, and takes about 15 m

Sponsors

Dr Jithin T Joseph
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosis of AUD according to DSM 5. Age 18-60 years, any gender. Person must have the capacity to give informed consent for the study. Right handed individuals ( Handedness will be assessed using Edinburg Handedness Inventory). Patient should have completed detoxification phase and should not be started on anti craving medications (the assements will be done before the initiation of anticraving agent, and it is feasible as the assement will only take 2-3 hours). Patient should not be taking benzodiazepines more than 2mg of lorazepam or equivalent. Patient should not have withdrawal symptoms at the time of recruitment (CIWA ar score less than or equal to 10). Inclusion Criteria for Healthy Controls: Healthy controls will be screened using modified MINI screen to ensure that they don’t have a diagnosis of major mental illness. Any gender, Age 18-60 years (Age and gender matching will be done for healthy controls according to the patient population). Right handed. Capacity to give written informed consent. HC should be abstinent from alcohol at least a week prior to the assessments.

Exclusion criteria

Exclusion criteria: Exclusion criteria for patients: Other substance use disorders except nicotine and caffeine use disorder. Other co morbid major mental health diagnosis. (Screening will be done using MINI adult Screen)Delirium tremens/complicated withdrawal A score of 15 or below in SADQ scale (mild AUD).Pregnancy / Post-Partum.Any contra indication for TMS assessments or TMS/tDCS treatment.Co-morbid neurological/medical disease that can affect the brain structure/function.(Recent CVA, Recent MI, any structural brain lesions like tumours, or any CNS infections) Exclusion criteria for Healthy Controls- Diagnosis of a psychiatric disorder.Family history of psychiatric disorder in any of the first-degree relatives.Current psychoactive substance dependence (except caffeine)Pregnancy / Post-Partum.Any contra indication for TMS assessments (only baseline TMS assessments will be done for healthy controls, and they will not receive single session iTBS) .Co-morbid neurological/medical disease that can affect the brain structure/function.

Design outcomes

Primary

MeasureTime frame
Stop Signal Reaction Time (SSRT)Timepoint: baseline & after single session of iTBS.

Secondary

MeasureTime frame
alcohol cravingTimepoint: baseline & after single session of itbs.

Countries

India

Contacts

Public ContactDr Samir Kumar Praharaj

Kasturba Medical College, Manipal

jtjthekkel1@gmail.com9846292668

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026